scholarly journals 2477 Targeting pulsatile load to increase exercise capacity and quality of life after TAVR for severe aortic stenosis

2018 ◽  
Vol 2 (S1) ◽  
pp. 48-48
Author(s):  
Anupam Kumar ◽  
Julio Chirinos
Keyword(s):  
Quality Of Life ◽  
Aortic Stenosis ◽  
Exercise Capacity ◽  
Severe Aortic Stenosis ◽  
Myocardial Strain ◽  
Study Drug ◽  
Potassium Nitrate ◽  
Exercise Intolerance ◽  
Double Blind

OBJECTIVES/SPECIFIC AIMS: The objective of the study is to test the effect of oral inorganic nitrate on the primary outcomes of exercise capacity and quality of life in patients who have undergone TAVR for severe aortic stenosis. We will also test the effect of the study drug on various physiology endpoints, including systemic vasodilator response to exercise, LV diastolic function and myocardial strain, late systolic LV load and pulsatile arterial wave reflections. METHODS/STUDY POPULATION: This is a randomized double-blind crossover clinical trial, in which 24 subjects who underwent TAVR for severe AS 3 or more months before enrollment will receive the following 2 interventions, in randomized order: (1) Potassium nitrate (KNO3), at a dose of 12–18 mmol/day by mouth for ~4 weeks, or (2) Potassium chloride (KCl), at a dose of 12–18 mmol/day by mouth for ~4 weeks. A 1-week washout period will be introduced between the 2 interventions. RESULTS/ANTICIPATED RESULTS: We hypothesize that sustained oral administration of potassium nitrate will lead to improvement of exercise capacity and quality of life in this population.DISCUSSION/SIGNIFICANCE OF IMPACT: His study will have a significant impact on assessment and management of patients after TAVR. We will gain a better understanding of physiologic abnormalities leading to exercise intolerance after TAVR. In addition, there are currently no proven therapies that improve exercise capacity in this population.

scholarly journals Aortic stenosis and diabetes mellitus: An ominous combination

2019 ◽  
Vol 16 (4) ◽  
pp. 310-323 ◽  
Author(s):  
Marko Banovic ◽  
Lavanya Athithan ◽  
Gerry P McCann
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Aortic Stenosis ◽  
Therapeutic Approach ◽  
Severe Aortic Stenosis ◽  
Significant Morbidity ◽  
Therapeutic Approaches ◽  
The Relationship ◽  
Insight Into

Aortic stenosis and diabetes mellitus are both progressive diseases which, if left untreated, result in significant morbidity and mortality. There is evidence that the prevalence of diabetes is substantially increased in patients with aortic stenosis and those with diabetes have increased rates of progression from mild to severe aortic stenosis. There are good data supporting the hypothesis that aortic stenosis and diabetes mellitus are associated with diabetes mellitus being detrimental towards the quality of life and survival of patients. Thus, a thorough understanding of the pathogenesis of both of these disease processes and the relationship between them aids in designing appropriate preventive and therapeutic approaches. This review aims to give a comprehensive and up-to-date insight into the influence of diabetes mellitus on patients with degenerative aortic stenosis, as well as the prognosis and therapeutic approach to these patients.

Can TAVI Improve Quality of Life in Elderly Patients with Severe Aortic Stenosis? A Single Centre Experience

2010 ◽  
Vol 19 ◽  
pp. S211-S212
Author(s):  
S. Lockwood ◽  
I. Meredith ◽  
P. Antonis ◽  
J. Harley ◽  
P. Mottram ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aortic Stenosis ◽  
Elderly Patients ◽  
Severe Aortic Stenosis ◽  
Improve Quality ◽  
Single Centre ◽  
Single Centre Experience

scholarly journals Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial

Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2193-2202 ◽  
Author(s):  
Seung Cheol Shim ◽  
Ljubinka Božić-Majstorović ◽  
Alfredo Berrocal Kasay ◽  
Elias Chalouhi El-Khouri ◽  
Fedra Irazoque-Palazuelos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Drug Infusion ◽  
Phase 3 ◽  
Double Blind ◽  
American College Of Rheumatology ◽  
Extension Period

Abstract Objective To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods Patients received 48 weeks’ treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48–72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.

scholarly journals Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center

2021 ◽  
Vol 10 (22) ◽  
pp. 5408
Author(s):  
Szymon Jonik ◽  
Michał Marchel ◽  
Ewa Pędzich-Placha ◽  
Zenon Huczek ◽  
Janusz Kochman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Severe Aortic Stenosis ◽  
Heart Team ◽  
Secondary Endpoints

Background: This retrospective study was proposed to investigate outcomes of patients with severe aortic stenosis (AS) after implementation of various treatment strategies following dedicated Heart Team (HT) decisions. Methods: Primary and secondary endpoints and quality of life during a median follow-up of 866 days of patients with severe AS qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and transcather aortic valve replacement (TAVR) or OMT and surgical aortic valve replacement (SAVR) were evaluated. As the primary endpoint composite of all-cause mortality, non-fatal disabling strokes and non-fatal rehospitalizations for AS were considered, while other clinical outcomes were determined as secondary endpoints. Results: From 2016 to 2019, 176 HT meetings were held, and a total of 482 participants with severe AS and completely implemented HT decisions (OMT, TAVR and SAVR for 79, 318 and 85, respectively) were included in the final analysis. SAVR and TAVR were found to be superior to OMT for primary and all secondary endpoints (p < 0.05). Comparing interventional strategies only, TAVR was associated with reduced risk of acute kidney injury, new onset of atrial fibrillation and major bleeding, while the superiority of SAVR for major vascular complications and need for permanent pacemaker implantation was observed (p < 0.05). The quality of life assessed at the end of follow-up was significantly better for patients who underwent TAVR or SAVR than in OMT-group (p < 0.05). Conclusions: We demonstrated that after careful implementation of HT decisions interventional strategies compared to OMT only provide superior outcomes and quality of life for patients with AS.

scholarly journals Efficacy and Safety of Jin-Shui Huan-Xian Granule for Idiopathic Pulmonary Fibrosis: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Shu-guang Yang ◽  
Xue-qing Yu ◽  
Jiansheng Li ◽  
Yang Xie ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Pulmonary Function ◽  
Exercise Capacity ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Acute Exacerbations

Abstract Background Idiopathic pulmonary fibrosis is a critical disease with poor prognosis. Although different studies have been conducted for the treatment of idiopathic pulmonary fibrosis, limited treatments are available. Jin-shui Huan-xian granule, which is a Chinese medicine herbal compound, has shown a promising efficacy in reducing frequencies of acute exacerbations, improving exercise capacity the quality of life of patients for idiopathic pulmonary fibrosis. Subjects and Methods: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 312 idiopathic pulmonary fibrosis patients will be enrolled and randomly allocated to one of the two groups with 1:1. After a 2-week washout period, 52-week treatment will also be performed for all the patients. Patients in experimental group will be given Jin-shui Huan-xian granule with Jin-shui Huan-xian placebo for control group. Outcome measures including acute exacerbations, pulmonary function, dyspnea, exercise capacity, quality of life will be evaluated in this study. Discussion Based on our previous study, it is hypothesized that JHG will reduce the acute exacerbations, improve exercise capacity, pulmonary function, quality of life, delay the disease progression-free. High-level evidence-based support for TCM in IPF will also be obtained in this study. Trial registration: http:www.clinicaltrials.gov : NCT04187690. Register data: December 11, 2019.

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